Regulatory Manager (CTA/IMPD/Biosimilar)

Scotland  ‐ Onsite
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Description

Position: Regulatory Affairs Manager

Salary: Up to £60,000

Location: Scotland

My client is looking for someone to join Europe's fastest growing specialty pharmaceutical companies. If you have the ability to liaise with other departments within your market area and are a committed and valued person to your regulatory team then please do read on.

Description:
  • Progress Regulatory activities associated with worldwide development, including development of key regulatory strategy, due diligence, gaining regulatory approvals for clinical trial and marketing applications and the maintenance of these authorisations where appropriate.
  • Defining project and product regulatory strategy of the Development Group in line with commercial and company strategy, consulting with appropriate departments where necessary, to include:
  • Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice
  • Management of the regulatory activities associated with project team plans
  • Management of compliance with relevant regulatory legislation and guidelines
  • Management of the preparation, attendance and follow-up of meetings with Regulatory Agencies (e.g. requests for scientific advice) including the generation of briefing documents and minutes
  • Management of the production of paper and electronic regulatory submissions including applications for clinical trials and marketing authorisations
  • Ensuring maintenance of clinical trial authorisations
  • Provide support for regulatory activities associated with due diligence for in- and out-licensing activities
  • Management of the provision of information requested by regulatory authorities
  • Ensuring effective communications between the Development Group and regulatory authorities, licensing partners and country contacts
  • Involvement in Regulatory Associates' development and training
  • High regulatory affairs knowledge - Effective leadership, interpersonal and management skills
  • Excellent negotiation, verbal and written communication, with the ability to understand and present complex scientific arguments
  • Strategic thinking with the ability to develop global regulatory strategy whilst balancing local/affiliate needs
  • Good analytical and problem solving skills, with excellent attention to detail
  • Good organisational and project management skills


If this is something you would consider then please do give me a call on .

Alternatively you could email me on L.khan(a)realstaffing.com

Referrals are always rewarded.

Kind regards,

Latifah Khan
Start date
07/2015
From
Real Staffing
Published at
27.07.2015
Project ID:
953409
Contract type
Permanent
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